Job DescriptionThe mission of our company’s Research Laboratory Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies.The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our company's Research Laboratory Quality Assurance and is accountable for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS).The Senior Specialist role reports into the Global Quality Systems organization, within CQMS, and is responsible for the execution of quality systems activities in support of the clinical supply chain for investigational medicinal product within our company's Global network. This role supports the digital enablement of quality systems, such as document control, deviation management, change control and quality risk management and will be instrumental in the development and implementation of new IT solutions quality system modules for these areas.The responsibilities of this role include, but are not limited to:
Provide key quality systems support and ensure that systems and processes are operating in a state of control and in compliance with regulatory requirements and internal SOPs.
Support the document control function, including the oversight of the Electronic Document Management Systems (EDMS) and training systems, issuance and archival of GMP documentation and revision of SOPs, primarily through the management of document lifecycle (new or existing documents) and review/approval workflows.
Support and drive the ongoing implementation and long-term maintenance of a new QMS, including Development Quality Standards and Development Global Standard Operating Procedures for all Clinical Supply sites within our company's Global network.
Leverage project management skills to support the digital enablement of quality systems, such as document control, deviation management, change control and quality risk management.
Support the planning, coordination, implementation, and organizational change management of IT initiatives from a business perspective, such as system enhancements and automation to improve clinical supply GMP processes.
Work to significantly harmonize diverse Clinical Supply site practices by developing efficient, yet flexible Global SOPs and effectively implement at all sites with Clinical Supply functions.
Support key quality system and compliance projects within the global network aimed at elevating our compliance posture and enhancing our quality systems.
Proactively identify, develop and implement opportunities for improvement and efficiency; with the goal of continuously improving processes.
Work across multiple organizations to solicit internal and external feedback and to influence and implement solutions.
Promote a culture of quality and operational excellence.
Author, review and/or approve GMP documents, as per procedures or need
Support training curriculum development, review and optimization
Support the development of quality metrics and KPIs to monitor the performance of the quality systems.
Education Minimum Requirement:
B.S degree in an appropriate Science or Engineering discipline or 5 years’ experience (equivalent).
Required Experience and Skills:
Experience in pharmaceutical/biotechnology industry with three (3) years in a technical, quality or compliance role.
Knowledge of GxPs and technical aspects of support areas are required.
Excellent communication and presentation skills with the ability to effectively collaborate with cross-functional and cross-divisional teams and stakeholders at all levels.
Ability to prioritize and manage multiple projects simultaneously, ensuring timely delivery and meeting business objectives.
Highly organized with effective project management skills.
Preferred Experience and Skills:
Previous background directly related to quality assurance, quality systems, auditing, quality management systems or other GMP compliance activities.
Strong computer skills, experience with Veeva Vault Quality Platform
Effective negotiation and problem-solving skills.
Ability to lead teams in a matrix organization to achieve objectives, including collaboration, influence without authority.
MSJRCurrent Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.Expected US salary range:$101,100.00 - $159,100.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):NoJob Posting End Date:12/7/2024A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Requisition ID: R323113